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Autism Spectrum Ambassador Program (ASAP) in the ED

Primary Purpose

Autism Spectrum Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assigned Ambassador
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Austism, Ambassador

Eligibility Criteria

30 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Study Participants:

  1. Must be children 30 months to 17 years of age.
  2. Study participants will be boys and girls.
  3. Study participants will have a a diagnosis of Autism Spectrum Disorder.
  4. Study participants will be presenting through the pediatric emergency room at the Penn State Hershey Medical Center.
  5. Study participants must be English Speaking.

2. Medical Student Ambassadors:

  1. Ambassadors must be enrolled as first, second, third, or fourth year medical students at the Penn State College of Medicine
  2. Ambassadors must complete training successfully

Exclusion Criteria:

1. Study Participants:

  1. Children under 30 months or older than 17 years.
  2. Children who do not have a diagnosis of Autism Spectrum Disorder.
  3. Children who cannot understand and communicate in English.

2. Medical Student Ambassadors:

  1. Individuals who are not a medical student at the Penn State College of Medicine.
  2. Medical students who do not complete the training course.
  3. Medical students who are not deemed appropriate the ASAP Ambassador role as per the discretion of study personnel.

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Assigned Ambassador (Intervention Group)

Control Group

Arm Description

Patients who were consented, completed the accommodations survey, and for whom a medical student was available during the time of the ED visit will serve as our intervention group. The participants will be assigned an Ambassador throughout the child's ED visit and will complete a patient satisfaction survey afterwards. The investigators hold to enroll 120 controls.

Patients who were consented, completed the accommodations survey, but for whom a medical student was not available during the time of the ED visit will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the ED visit, however no ambassador will be assigned during the ED visit. The investigators hope to enroll 120 controls.

Outcomes

Primary Outcome Measures

Patient Satisfaction Survey (Questionnaire)
Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap. The questionnaire, likely titled "ASAP Patient Satisfaction Survey", will include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied.

Secondary Outcome Measures

Medical Student Satisfaction Survey (Questionnaire)
Overall medical student satisfaction with the ambassador program; data collected using REDCap.The questionnaire, likely titled "ASAP Medical Student Satisfaction Survey", will include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied.
Medical Student Career Interest (Questionnaire)
Medical student career interests before and after participation in this program; data collected using REDCAP. The questionnaire, likely titled "Impact of ASAP on Career Interest" may include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied but will also include unscaled questions with answers such as "very interested, somewhat interested, not interested, etc.".
Medical Student Comfort Level (Questionnaire)
Medical student comfort level interacting with autistic children before and after participation in the program; data collected using REDCap.The questionnaire, likely titled "Impact of ASAP on Medical Student Comfort Levels with Patients with Autism", may include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied among unscaled questions with answers such as "very comfortable, neutral, and very uncomfortable."

Full Information

First Posted
December 2, 2019
Last Updated
April 8, 2021
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04186364
Brief Title
Autism Spectrum Ambassador Program (ASAP) in the ED
Official Title
Implementation and Evaluation of the Autism Spectrum Ambassador Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Terminated due to COVID-19 pandemic.
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
April 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are evaluating the implementation and the effectiveness of a medical student staffed support program (ASAP) for children diagnosed with Autism Spectrum Disorder coming into Penn State Hershey Children's Hospital Emergency Department. The ASAP program involves training and assigning a medical student as an Ambassador to help advocate for the special needs of a child with ASD. This study is designed to compare patient satisfaction of children and families who are assigned an Ambassador to those who are not assigned an Ambassador during their time in the Emergency Department. The secondary objectives are to measure overall medical student satisfaction with the program, medical student career interests before and after participation, and medical student comfort level interacting with children with ASD before and after participation.
Detailed Description
The Autism Spectrum Ambassador Program (ASAP) is a medical student staffed program designed to improve the experience for children with Autism Spectrum Disorder coming into the Children's Hospital Emergency Department (ED) for an acute visit. This program will pair an interested and trained medical student with a family whose child presents to the Children's Hospital ED and identifies as having Autism and requiring special accommodations to improve cooperation and procedure tolerance. Patients will be identified by the study team members, who are ages 30 months to 17years with the diagnosis of Autism Spectrum Disorder. Participants will be recruited through posters and flyers in the Pediatric Emergency Room Waiting area; families who are interested in enrolling will enter the research study. Interested caregivers will be asked to complete a confidential survey that will identify areas that can be accommodated during their visit. This survey will then be automatically be printed for the ED staff and ambassador to review. The student will meet the family in the ED and accompany the family through their visit; the student will print the child's Accommodation Plan, place it at the bedside, and make it available for each member of the treatment team. Students will be trained to chart a child's Accommodation Plan for each member of the treatment team and place it at bedside, as well to advocate on behalf of the child and their family, communicate with the staff (including nurses, primary care providers (physicians and Physician Assistants (PAs)), and techs (radiology, phlebotomy, transport). To the extent possible, the investigators hope that having a student advocate, educate staff in the ED, and implement changes as needed will improve patient satisfaction with the experience and improve the ease with which a procedure can be carried out for a child with ASD. Students will also be queried as to the experience and survey data will be used to improve the program over time. Training will be completed so that all members of the treatment team will be aware of the program and aware of the possible accommodations. Treatment team members will be provided additional training to enhance the success of the ASAP program and all treatment team members will be encouraged to work together for the best possible outcome for all patients. Treatment team services include: nursing, ED physicians, PAs, technicians (radiology, phlebotomy, transport), registration, and to the extent possible, the personnel involved in the care of these children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Austism, Ambassador

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assigned Ambassador (Intervention Group)
Arm Type
Experimental
Arm Description
Patients who were consented, completed the accommodations survey, and for whom a medical student was available during the time of the ED visit will serve as our intervention group. The participants will be assigned an Ambassador throughout the child's ED visit and will complete a patient satisfaction survey afterwards. The investigators hold to enroll 120 controls.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients who were consented, completed the accommodations survey, but for whom a medical student was not available during the time of the ED visit will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the ED visit, however no ambassador will be assigned during the ED visit. The investigators hope to enroll 120 controls.
Intervention Type
Behavioral
Intervention Name(s)
Assigned Ambassador
Intervention Description
If assigned to the intervention group, participants will be assigned a medical student ambassador on arrival to the Emergency Department. A brief discussion may take place to review the child's history and survey results, and a copy of the survey will be placed near the patient's bedside for healthcare personnel to review. The student ambassador will accompany the child and their family through key points of their visit and will be expected to make accommodations for the child as determined by the accommodation survey results. The family will be required to allow the ambassador to stay throughout the ED visit.
Primary Outcome Measure Information:
Title
Patient Satisfaction Survey (Questionnaire)
Description
Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap. The questionnaire, likely titled "ASAP Patient Satisfaction Survey", will include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied.
Time Frame
1 year.
Secondary Outcome Measure Information:
Title
Medical Student Satisfaction Survey (Questionnaire)
Description
Overall medical student satisfaction with the ambassador program; data collected using REDCap.The questionnaire, likely titled "ASAP Medical Student Satisfaction Survey", will include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied.
Time Frame
1 year
Title
Medical Student Career Interest (Questionnaire)
Description
Medical student career interests before and after participation in this program; data collected using REDCAP. The questionnaire, likely titled "Impact of ASAP on Career Interest" may include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied but will also include unscaled questions with answers such as "very interested, somewhat interested, not interested, etc.".
Time Frame
1 year
Title
Medical Student Comfort Level (Questionnaire)
Description
Medical student comfort level interacting with autistic children before and after participation in the program; data collected using REDCap.The questionnaire, likely titled "Impact of ASAP on Medical Student Comfort Levels with Patients with Autism", may include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied among unscaled questions with answers such as "very comfortable, neutral, and very uncomfortable."
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Study Participants: Must be children 30 months to 17 years of age. Study participants will be boys and girls. Study participants will have a a diagnosis of Autism Spectrum Disorder. Study participants will be presenting through the pediatric emergency room at the Penn State Hershey Medical Center. Study participants must be English Speaking. 2. Medical Student Ambassadors: Ambassadors must be enrolled as first, second, third, or fourth year medical students at the Penn State College of Medicine Ambassadors must complete training successfully Exclusion Criteria: 1. Study Participants: Children under 30 months or older than 17 years. Children who do not have a diagnosis of Autism Spectrum Disorder. Children who cannot understand and communicate in English. 2. Medical Student Ambassadors: Individuals who are not a medical student at the Penn State College of Medicine. Medical students who do not complete the training course. Medical students who are not deemed appropriate the ASAP Ambassador role as per the discretion of study personnel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Tierney, M.D.
Organizational Affiliation
Developmental Pediatrics, Penn State Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27011004
Citation
Gimbler Berglund I, Huus K, Enskar K, Faresjo M, Bjorkman B. Perioperative and Anesthesia Guidelines for Children with Autism: A Nationwide Survey from Sweden. J Dev Behav Pediatr. 2016 Jul-Aug;37(6):457-64. doi: 10.1097/DBP.0000000000000289.
Results Reference
background
PubMed Identifier
24122446
Citation
Nayfack AM, Huffman LC, Feldman HM, Chan J, Saynina O, Wise PH. Hospitalizations of children with autism increased from 1999 to 2009. J Autism Dev Disord. 2014 May;44(5):1087-94. doi: 10.1007/s10803-013-1965-x.
Results Reference
background
PubMed Identifier
26908475
Citation
Broder-Fingert S, Shui A, Ferrone C, Iannuzzi D, Cheng ER, Giauque A, Connors S, McDougle CJ, Donelan K, Neumeyer A, Kuhlthau K. A Pilot Study of Autism-Specific Care Plans During Hospital Admission. Pediatrics. 2016 Feb;137 Suppl 2:S196-204. doi: 10.1542/peds.2015-2851R.
Results Reference
background
Links:
URL
http://irb.psu.edu
Description
Study Protocol
URL
http://irb.psu.edu
Description
Informed Consent Form
URL
http://irb.psu.edu
Description
Accommodation Survey
URL
http://irb.psu.edu
Description
Patient Satisfaction Survey
URL
http://irb.psu.edu
Description
Medical Student Survey
URL
http://irb.psu.edu
Description
Summary Explanation of Research - for Medical Students

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Autism Spectrum Ambassador Program (ASAP) in the ED

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